SIMCOR SUMMARY
SIMCOR tablets contain niacin extended-release (NIASPAN) and simvastatin in combination. Simvastatin, an inhibitor of HMG-CoA reductase, and niacin are both lipid-altering agents. Niacin Extended-Release is an extended release form of nicotinic acid, or 3-pyridinecarboxylic acid.
SIMCOR (simvastatin/niacin) is indicated for the following:
Patients with Hypercholesterolemia Requiring Modifications of Lipid Profiles
SIMCOR
SIMCOR is indicated to reduce total-C, LDL-C, Apo B, non-HDL-C, or TG, or to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson type IIa and IIb) when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate.
SIMCOR is indicated to reduce TG in patients with hypertriglyceridemia (Fredrickson type IV hyperlipidemia) when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate.
Limitations of use
No incremental benefit of SIMCOR on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin monotherapy and niacin monotherapy has been established.
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.
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NEWS HIGHLIGHTS
Published Studies Related to Simcor (Simvastatin / Niacin)
Atheroprotective lipoprotein effects of a niacin-simvastatin combination compared to low- and high-dose simvastatin monotherapy. [2009.04]
BACKGROUND: Niacin has multiple lipoprotein effects that may provide cardiovascular benefit when added to statin monotherapy... CONCLUSIONS: We demonstrate that full-dose niacin/moderate-dose simvastatin combination has sustained benefits on atherogenic apoB lipoproteins, at least comparable to high-dose simvastatin, while also raising HDL-cholesterol. Results of large clinical trials will inform whether niacin-statin combinations reduce cardiovascular disease events.
Comparison of the safety and efficacy of a combination tablet of niacin extended release and simvastatin vs simvastatin monotherapy in patients with increased non-HDL cholesterol (from the SEACOAST I study). [2008.05.15]
The efficacy and safety of 2 regimens of a combination of a proprietary niacin extended release plus simvastatin (NER/S; 1,000/20 and 2,000/20 mg/day) were compared with simvastatin monotherapy (20 mg/day) for 24 weeks in 319 high-risk patients with predominantly mixed dyslipidemia who were already at National Cholesterol Education Program Adult Treatment Panel III risk-adjusted goals for low-density lipoprotein cholesterol...
Lipid-altering efficacy and safety of ezetimibe/simvastatin coadministered with extended-release niacin in patients with type IIa or type IIb hyperlipidemia. [2008.04.22]
OBJECTIVES: This study evaluated the safety and lipid-altering efficacy of ezetimibe/simvastatin (E/S) coadministered with extended-release niacin (N) in patients with type IIa or IIb hyperlipidemia. BACKGROUND: Current guidelines recommend consideration of combination drug therapy to achieve optimal low-density lipoprotein cholesterol (LDL-C) lowering and broader lipid-altering effects when treating hypercholesterolemic patients at high risk for atherosclerotic cardiovascular events... CONCLUSIONS: Combination treatment with E/S plus N showed superior lipid-altering efficacy compared with N or E/S in type IIa or IIb hyperlipidemia patients and was generally well tolerated aside from N-associated flushing. This combination offers an effective, broad, lipid-altering therapy with improvements in lipid effects beyond LDL-C in these patients. (To Evaluate Ezetimibe/Simvastatin and Niacin [Extended Release Tablet] in Patients With High Cholesterol.
A randomized multicenter comparison of basiliximab and muromonab (OKT3) in heart transplantation: SIMCOR study. [2006.06.15]
BACKGROUND: Antilymphocytic antibodies have been long used for the prevention of acute rejection early after heart transplantation (HTx), but their adverse effects have limited their widespread use. Our aim was to evaluate the safety, tolerability, and efficacy of the novel anti-CD25 antibody basiliximab (BAS) compared with muromonab (OKT3)... CONCLUSION: In this HTx study, induction therapy with BAS was safer and better tolerated than OKT3, without significant differences in efficacy outcomes.
An open-label, crossover study of the pharmacokinetics of Insoluble Drug Delivery-MicroParticle fenofibrate in combination with atorvastatin, simvastatin, and extended-release niacin in healthy volunteers. [2006.01]
BACKGROUND: Fenofibrate has been prescribed concomitantly with other lipid-lowering agents as a treatment for dyslipidemia. However, combination therapy, particularly a statin-fibrate combination, may be associated with an increased risk of myopathy, although this risk appears to be less with fenofibrate than with other fibrates. OBJECTIVE: The objective of this study was to determine the effect of administering a single dose of atorvastatin, simvastatin, or extended-release (ER) niacin on the pharmacokinetics and safety of a single dose of fenofibrate Insoluble Drug Delivery-MicroParticle (IDD-P)... CONCLUSIONS: Concomitant administration of a single dose of either atorvastatin or simvastatin had no significant effect on the pharmacokinetics of a single dose of IDD-P fenofibrate. A drug interaction between concomitantly administered single doses of IDD-P fenofibrate and ER niacin could not be ruled out.
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Page last updated: 2009-10-20
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